Long‐term clinical results and quality of life after insertion of a self‐expanding flexible endourethral prosthesis

Abstract

To evaluate the safety and efficacy of the Urolume self-expanding flexible endourethral stent, based on a long-term follow-up, and to determine its role amongst the various modalities of treatment available for the relief of bladder outlet obstruction (BOO) arising from benign prostatic hyperplasia (BPH). From January 1991 to April 1992, the Urolume wallstent (American Medical Systems, USA) was placed successfully in each of 62 patients (aged 50-89 years) who had significant subjective and objective evidence of BOO. The stent was placed as a daycase procedure under general anaesthesia. Pre-operatively, each patient was assessed fully in an out-patient clinic by symptoms, a flow rate measurement and a rectal examination. Post-operatively, patients were assessed using transrectal ultrasonography, cystoscopy, symptoms and flow rate measurement, and after 5 years, the International Prostate Symptom Score and satisfaction score were obtained. After 5 years, 27 (39%) patients survived and 10 (14%) died with their Urolume stent intact; 22 (32%) completed the follow-up and five refused or were lost to follow-up. Day and night-time frequencies and flow rates improved continuously. Complete epithelialization occurred in 16 of the 22 patients assessed. Of those in whom the Urolume was removed, 20 are alive and five dead. The effectiveness of the Urolume in improving symptoms and flow rates in patients with BPH was confirmed. However, the high failure rate arose largely from inexperience in selection and deployment. There are no absolute criteria to predict a successful outcome. This study confirms the Urolume as a safe device. Most patients whose symptoms settled in the first year maintained a good flow rate and a significant improvement in symptoms for 5 years; their quality of life at the last follow-up was good.